ICARUS: Inhaled Corticosteroid And Real life Unlicensed Spacer use – stage 2 (ICARUS 2)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17815
• EU PAS number:
  EUPAS13194
• Study ID:
  17815
• Official title and acronym:
  ICARUS: Inhaled Corticosteroid And Real life Unlicensed Spacer use – stage 2 (ICARUS 2)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Examining the real-life unlicensed and licensed use of inhaled corticosteroids with spacers in patients with asthma in the United Kingdom comparing non extra fine beclomethasone in Aerochamber and Volumatic spacers
• Study status:
  Ongoing

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 18/04/2016

Actual: 27/10/2016

Study start date

Planned: 03/01/2017

Actual: 03/01/2017

Data analysis start date

Planned: 04/01/2017

Actual: 04/01/2017

Date of interim report, if expected

Planned: 17/02/2017

Date of final study report

Planned: 24/02/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

chiesi

Study protocol

Initial protocol

20161028_R00616_Chiesi_ICARUS2_protocol_v1.3

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable